RecruitingNCT07249788REZMASHUpdated Dec 3, 2025

Resmiterom Efficacy & Safety in Patients With MASH

A Phase 4 interventional study of Resmetirom in MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Nabiqasim Industries (Pvt) Ltd. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Nabiqasim Industries (Pvt) Ltd · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 165
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.

Conditions studied

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Keywords

Resmetirom
MASH
Safety
Efficacy

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

- At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)
  - Clinical diagnosis of MASH using:
    - LSM ≥ 8.5kpa And/or
    - FAST score ≥0.67 And/or
    - FibroScan CAP ≥ 275 dB/m And/or
    - FIB-4 > 1.3

Exclusion criteria

Exclusion Criteria:

- History of drug addiction and alcoholism
  - Cirrhosis or decompensated liver disease
  - Chronic viral hepatitis HBV, HCV)
  - MACE including MI, Stroke, PE etc.
  - Pregnant/lactating women
  - Concurrent use of other investigational drugs
  - History of other liver diseases (viral, autoimmune, drug-induced, alcohol)
  - Previous use of resmetirom in last 6 months
  - Significant renal impairment (eGFR \<30)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 165 participants (estimated)

Study arms

Experimental
MASH targeted therapy
MASH fibrosis stage 2 or 3
Drug: Resmetirom

Interventions

DrugResmetirom
1st FDA approved MASH therapy

What researchers measure

Primary outcomes

FIB-4 and CAP score/LSM on fibroscan
Changes in liver fibrosis using non invasive markers
Time frame: 6 months
Changes in thyroid profile
thyroid profile of each patient at baseline and at primary end point
Time frame: 6 months

Study locations

1 of 1 sites recruiting

Liver transplant center, Holy family hospital
Rawalpindi, Punjab Province, Pakistan
- Shanila Akhter · Contact · 'shanilaakhter105@gmail.com' · +92 307 6738460
- Dr Anum Shakeel · Contact
- Dr. Muhammad Umar · Principal investigator
- Dr Anum Shakeel · Principal investigator
- Dr. Bushra Khar · Sub investigator
- Dr Sadia Khan · Sub investigator
- Dr Tayyab Sb. · Sub investigator
Recruiting

References and documents

Publications

Patel RH, Parikh C, Upadhyay H, Sonaiya S, Ramnath P, Singh S, Patel U, Kothari T. Resmetirom in the Management of Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Comprehensive Review of Current Evidence and Therapeutic Potential. Cureus. 2024 Nov 29;16(11):e74772. doi: 10.7759/cureus.74772. eCollection 2024 Nov. PubMed 39735033 ↗
Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27. PubMed 34329774 ↗
Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11. PubMed 31727409 ↗
Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. PubMed 38324483 ↗

Individual participant data

Plan to share: Undecided — Its undecided for now will be updated laterwards

Registry details

Key details

Study ID: NCT07249788
Lead sponsor: Nabiqasim Industries (Pvt) Ltd
Responsible party: Sponsor
First posted: Nov 25, 2025
Start date: Oct 17, 2025
Primary completion: Oct 16, 2026 (estimated)
Completion: Dec 31, 2026 (estimated)
Last update: Dec 3, 2025

Study contacts

Hussain B Abidi, MBBS, MBA, CRCP

Contact

MDR.hussainabidi@gmail.com

+923322583236

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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